Cholestech LDX Manual
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Cholestech LDX Manual

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Summary of Contents for Cholestech LDX

  • Page 1 System Procedure Manual < TABLE OF CONTENTS...
  • Page 2 > TABLE OF CONTENTS...

  • Page 3: Table Of Contents

    1.2 Cholestech LDX Optics Check Cassette ........2...
  • Page 4 TABLE OF CONTENTS Cholestech LDX System Procedure Manual 6.0 Material Safety Data Sheets ..........30 7.0 Proficiency Testing...
  • Page 5 Cholestech LDX System Procedure Manual Foreword Procedure Manual Overview This procedure manual has been designed to instruct Cholestech LDX users in how to comply with good laboratory practices and assist in complying with applicable regulations. The Cholestech LDX System Procedure Manual covers: •...
  • Page 6 INTRODUCTION Cholestech LDX System Procedure Manual Introduction Overview of a Quality Assurance Program Quality assurance (QA) is a comprehensive set of policies, procedures and practices necessary to ensure the quality of laboratory tests. Its purpose is to ensure that over the long term, the laboratory provides reliable data that accurately reflect the patient’s status.
  • Page 7 1.0 Setup and Maintenance < TABLE OF CONTENTS...

  • Page 8: Introduction

    After the Cholestech LDX System has been moved or serviced. 1.3 Optics Check Cassette Test Procedure Do not use a Cholestech LDX Optics Check Cassette that is expired, damaged or altered in any way. Press the RUN button. After verifying the “Selftest OK” message, the drawer will open,...

  • Page 9: Environmental Requirements

    The Instrument History Record allows lab personnel to communicate effectively with Cholestech Technical Service. You should have a record for your Cholestech LDX System as well as records for any other instruments in the lab.

  • Page 10: Cholestech Ldx System Initial Setup

    1.7 Cholestech LDX System Initial Setup The Initial Setup Checklist is provided to assure that all of the environmental conditions are met and that the Cholestech LDX System runs properly during the initial setup in the laboratory. The Instrument History Record can be used to record any service performed on the Cholestech LDX System or other instruments in your laboratory.

  • Page 11: Course Of Action If System Becomes Inoperable

    1.9 Course of Action If System Becomes Inoperable Course of Action for the Cholestech LDX System If the Cholestech LDX System becomes inoperable, call Cholestech Technical Service at 800-733-0404 or 510-732-7200. Until the instrument becomes operable, venous specimens will be drawn and sent to the following reference laboratory.

  • Page 12: Procedure Sign-Off

    SETUP AND MAINTENANCE Cholestech LDX System Procedure Manual 1.10 Procedure Sign-Off Approved Director’s Signature Date Adopted Director’s Signature Date Revised Director’s Signature Date Discontinued Director’s Signature Date The procedure is not applicable to this laboratory: Director’s Signature Date 1.11 Reference(s) and Bibliography National Committee for Clinical Laboratory Standards.

  • Page 13: 2.0 Specimen Collection And Handling

    2.0 Specimen Collection and Handling < TABLE OF CONTENTS...

  • Page 14: Introduction

    A warm hand and good blood flow from the puncture site are essential to draw a good capillary sample. The patient should sit quietly for five minutes before the blood sample is collected. Put a capillary plunger into a Cholestech capillary tube at the end with the red mark. Set it aside. <...

  • Page 15: Procedure Sign-Off

    SPECIMEN COLLECTION AND HANDLING Cholestech LDX System Procedure Manual Choose a spot on the side of one of the center fingers of either hand. The fingers and hands should be warm to the touch. To warm the hand, you can: a.

  • Page 16: Venipuncture Procedure

    When collecting several samples during a venipuncture, start with the tubes that have no additive, or a serum separator tube. * This is the appropriate tube for use with the Cholestech LDX System. Performing the Venipuncture Identify the patient by asking the patient to state his/her full name.
  • Page 17 SPECIMEN COLLECTION AND HANDLING Cholestech LDX System Procedure Manual Select the venipuncture site. Clean the venipuncture site with a 70% isopropyl alcohol pad, making one smooth circular pass of the venipuncture site. Allow the skin to dry to prevent hemolysis of the specimen and to prevent the patient from having a burning sensation when the venipuncture is performed.

  • Page 18: Procedure Sign-Off

    The following space is available to record the laboratory procedure that will be used to report results from the Cholestech LDX System. Or you may use the Patient Result Log in the Master Forms section.

  • Page 19: Procedure Sign-Off

    SPECIMEN COLLECTION AND HANDLING Cholestech LDX System Procedure Manual Instrument Name Manufacturer 2.7 Procedure Sign-Off Approved Director’s Signature Date Adopted Director’s Signature Date Revised Director’s Signature Date Discontinued Director’s Signature Date The procedure is not applicable to this laboratory: Director’s Signature Date <...

  • Page 20: Proper Specimen Storage

    30 minutes of collection. Use a MiniPet ™ Pipette and tips or a micropipetter calibrated to deliver 35 to 50 µL. Do not use the Cholestech capillary tubes for transferring venous whole blood, serum or plasma to a Cholestech LDX test cassette.

  • Page 21: Reference(S) And Bibliography

    SPECIMEN COLLECTION AND HANDLING Cholestech LDX System Procedure Manual 2.9 Procedure to Properly Remove a Rubber Stopper from an Evacuated Tube All blood samples and blood products are potentially biohazardous and should be treated as such. Gloves, goggles and a completely buttoned long-sleeve lab coat should be worn when handling these materials.
  • Page 22 < TABLE OF CONTENTS...

  • Page 23: 3.0 Quality Control

    3.0 Quality Control < TABLE OF CONTENTS...

  • Page 24: Introduction

    Choice of Material The preferred quality control material for use with the Cholestech LDX System is Cholestech LDX Level 1 and Level 2 Control Materials. If you choose to use an alternate quality control material, see Section 3.2. Handling of Material •...

  • Page 25: Establishing And Calculating A Control Range

    3.4 Establishing and Calculating a Control Range If the control materials you plan to use do not have ranges set for the Cholestech LDX, or if you prefer to set your own ranges, please follow this procedure. Before you start, order an adequate supply of control materials to last you several months.

  • Page 26: Cholestech Ldx System Quality Control Log

    We have provided you with a log sheet that can be duplicated and used for your records when you test quality control materials on the Cholestech LDX System. (See Master Forms section.) 3.6 When Results Are Outside Acceptable Control Limits...

  • Page 27: Procedure Sign-Off

    QUALITY CONTROL Cholestech LDX System Procedure Manual 3.8 Procedure Sign-Off Approved Director’s Signature Date Adopted Director’s Signature Date Revised Director’s Signature Date Discontinued Director’s Signature Date The procedure is not applicable to this laboratory: Director’s Signature Date 3.9 Reporting a Complaint Use this space if you wish to document the action taken when a patient complains of receiving erroneous test result(s).

  • Page 28: Procedure Sign-Off

    This procedure meets requirements for calibration verification and linearity testing. To verify calibration for the Cholestech LDX System, a linearity test is performed with a minimum of three samples over the measuring range for each analyte to be tested on the instrument.

  • Page 29: Reference(S) And Bibliography

    QUALITY CONTROL Cholestech LDX System Procedure Manual 3.12 Reference(s) and Bibliography National Committee for Clinical Laboratory Standards. Physician’s Office Laboratory Procedure Manual; Tentative Guideline . Villanova, Pa.: NCCLS; 1989. NCCLS publication POL2-T, Vol. 12, No. 5. Westgard JO, et al. Concepts and practices in the evaluation of clinical chemistry methods II: experimental procedures.
  • Page 30 < TABLE OF CONTENTS...

  • Page 31: 4.0 Safety

    4.0 Safety < TABLE OF CONTENTS...

  • Page 32: Introduction

    SAFETY Cholestech LDX System Procedure Manual Safety 4.1 Introduction The Occupational Safety & Health Administration (OSHA) ruled that beginning March 6, 1992, all labs must undergo training to protect the workers from bloodborne pathogens. The new regulations outline in detail what employees must be taught about the hazards of working with potentially infectious materials and what precautions must be taken to prevent or minimize exposure.

  • Page 33: 5.0 Training

    5.0 Training < TABLE OF CONTENTS...

  • Page 34: Introduction

    5.2 Cholestech LDX Training Checklist This checklist is designed to assist the trainer in training users of the Cholestech LDX System. There is room to date and sign each procedure as the task is completed. 5.3 Certificate of Training— Fingerstick Blood Collection This certificate can be used to document that fingerstick training has been completed and approved by a physician.
  • Page 35 6.0 Material Safety Data Sheets < TABLE OF CONTENTS...

  • Page 36: Material Safety Data Sheets

    Physical Data Fire & Explosion Data Health Information Reactivity Data Spill or Leak Procedures Personal Protection Information Special Precautions An MSDS for the Cholestech LDX test cassette product is included here. < TABLE OF CONTENTS For Information Only Recommended Optional Information...
  • Page 37 August 25, 1995 COMMON NAME (USED ON LABEL) CHEMICAL FAMILY Cholestech LDX TC Cassette, TC and HDL Panel Cassette, Lipid Profile Cassette, Does not apply TC/HDL/GLU Panel Cassette, Lipid Profile plus Glucose Cassette, TC and Glucose Cassette, Cholestech LDX Alanine Aminotransferase Test...
  • Page 38 MATERIAL SAFETY DATA SHEETS Cholestech LDX System Procedure Manual MATERIAL SAFETY DATA SHEET CONTINUED SECTION 5 – HEALTH INFORMATION PRIMARY ROUTES OF EXPOSURE Skin SIGNS AND SYMPTOMS OF EXPOSURE (1) ACUTE OVEREXPOSURE – None (2) CHRONIC OVEREXPOSURE – None MEDICAL CONDITIONS GENERALLY AGGRAVATED BY EXPOSURE...
  • Page 39 7.0 Proficiency Testing < TABLE OF CONTENTS...

  • Page 40: Proficiency Testing 7.1 Overview Of Proficiency Testing

    PROFICIENCY TESTING Cholestech LDX System Procedure Manual Proficiency Testing 7.1 Overview of Proficiency Testing Under CLIA ‘88, all laboratories conducting tests classified moderately complex and highly complex must participate in an approved proficiency testing (PT) program for each specialty they perform testing in.
  • Page 41 PROFICIENCY TESTING Cholestech LDX System Procedure Manual The specimen of choice for the Cholestech LDX System is a specimen of human serum with no stabilizers. The type of specimen provided presents a potential problem for some instruments and methodologies. Lyophilized serum has been the most frequently used sample for clinical chemistry proficiency surveys.

  • Page 42: Proficiency Testing Agencies

    Leawood, KS 66211-2672, 800-274-7911 (Ask for AAFP-PT) / FAX 816-361-8167. • Some state health departments. * These laboratories have been shown to correlate with minimal matrix effects on the Cholestech LDX. 7.3 Reference(s) and Bibliography National Committee for Clinical Laboratory Standards. Physician’s Office Laboratory Guidelines;...
  • Page 43 8.0 Glossary of Terms < TABLE OF CONTENTS...

  • Page 44: Glossary Of Terms

    GLOSSARY OF TERMS Cholestech LDX System Procedure Manual Glossary of Terms Acceptable Control Range – range of results that indicate adequate performance when analyzing a control sample. The range is shown in the control’s product insert. Accuracy – correctness; freedom from error. The accuracy of results can be measured by comparing them with those from another laboratory (this is “...
  • Page 45 GLOSSARY OF TERMS Cholestech LDX System Procedure Manual Capillary (capillary action) – attraction between a liquid and a solid that causes the liquid to rise, as for example, into a capillary tube. Centrifuge – instrument that separates the lighter portions of a solution, mixture, or suspension from the heavier portions by centrifugal force.
  • Page 46 GLOSSARY OF TERMS Cholestech LDX System Procedure Manual Gravimetry – measurement of a substance by determining its weight or specific gravity. Hematoma – mass of blood, usually clotted, under the skin in an organ, space, or tissue caused by a break in the wall of a blood vessel.
  • Page 47 GLOSSARY OF TERMS Cholestech LDX System Procedure Manual Method – analytical method; the instructions including procedures, material, equipment, and everything else needed for an analyst to perform an analysis. Normal Values (Expected Values, Reference Values) – range of values established for each analyte, which includes the results expected when performing a test on a healthy person.
  • Page 48 GLOSSARY OF TERMS Cholestech LDX System Procedure Manual Quantitative – applied to tests that give results expressing the numerical amount of an analyte in a specimen. This is in contrast to qualitative tests that detect whether a particular analyte, constituent, or condition is present.

  • Page 49: Reference(S) And Bibliography

    GLOSSARY OF TERMS Cholestech LDX System Procedure Manual Standard, Secondary – reference material, the analyte concentration of which has been ascertained by reference to a primary standard. Standard Deviation – statistical measurement of the degree of variation from the mean of a series of measurements.
  • Page 50 < TABLE OF CONTENTS...

  • Page 51: Master Forms

    9.0 Master Forms < TABLE OF CONTENTS...
  • Page 52 OPTICS CHECK LOG Cholestech LDX Serial No. Acceptable Range Optics Check Cassette Lot No. Expiration Date RESULTS DATE PERFORMED BY ACCEPT REJECT COMMENTS Ch.1 Ch.2 Ch.3 Ch.4 < TABLE OF CONTENTS...
  • Page 53 TEMPERATURE CHART YEAR Record the temperature and initial the space provided. One sheet should be used per room, refrigerator, or freezer as your procedures dictate. Site ID Acceptable Temperature Range MARCH APRIL JUNE JULY SEPT < TABLE OF CONTENTS...
  • Page 54 INSTRUMENT HISTORY RECORD GENERAL INFORMATION Instrument Model No. Serial No. Date Purchased Cost Manufacturer Address City State Telephone Contact Person: Distributor Address City State Telephone Contact Person Warranty Contact Person Notes Technical Service Representative Telephone SERVICE RECORD Date Comments < TABLE OF CONTENTS...
  • Page 55 INFORMATION AND SERVICE LOG Instrument Serial No. Purchase Date Warranty Expires Customer Service Representative Phone No. Technical Service Representative Phone No. Sales Representative Phone No. DATE PROBLEM ACTION TAKEN OPERATOR < TABLE OF CONTENTS...
  • Page 56 INITIAL SETUP CHECKLIST Cholestech LDX Serial No. Date of Setup Name of Lab Person Performing Initial Setup Signature Approval by Laboratory Director FACILITY SPECIFICATIONS OPERATOR DATE 1. Room temperature: 68–87°F (20–31°C) 2. Stable work surface free from vibrations 3. Isolation from direct heat and light sources (e.g., sunlight, ovens, room heater, etc.) 4.
  • Page 57 EQUIPMENT MAINTENANCE / CLEANING LOG INSTRUMENT NAME MAINTENANCE NOTES (problems reported, dates, solutions) Serial No. Quarterly Cleaning Schedule Dates < TABLE OF CONTENTS...
  • Page 58 INSTRUMENTS IN-USE RECORD INSTRUMENT/ SERIAL MANUFACTURER DATE OPERATOR MODEL NUMBER INSTALLED < TABLE OF CONTENTS...
  • Page 59 PATIENT RESULT LOG Cassette Lot No. Expiration Date Cholestech LDX Serial No. DATE OPERATOR PATIENT NAME PATIENT ID GLU HDL LDL TC/HDL ALT < TABLE OF CONTENTS...

  • Page 60: Patient Result Label Log No

    PATIENT RESULT LABEL LOG NO. 1 Cholestech LDX Serial No. Operator Cassette Lot No. Expiration Date Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here...
  • Page 61 PATIENT RESULT LABEL LOG NO. 2 Cholestech LDX Serial No. Operator Cassette Lot No. Expiration Date Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here <...
  • Page 62 QUALITY CONTROL LOG Cholestech LDX Serial No. Control Range Control Lot Expiration Date Control Level DATE CASSETTE LOT NO. ANALYTE VALUE ACCEPT REJECT OPERATOR COMMENTS / ACTION TAKEN < TABLE OF CONTENTS...
  • Page 63 – – REFRIG TEMP Level 1 (mg/dL) – – – – – Level 2 (mg/dL) CHOLESTECH LDX SERIAL NO. CONTROL RESULTS Accept Reject Level 1 Level 2 DATE Control Level 1 Lot No. Expiration Date OPERATOR Control Level 2 Lot No.
  • Page 64 CONTROL RANGE CALCULATION FORM Control Name Lot No. Analyte Cassette Lot No. Cholestech LDX Serial No. Accept Reject Director Approval Approval Date 1. Record the date in Column 2 and the initials in Column 3. – – Date Init. Result Result –...
  • Page 65 Cassette Expiration Date REFERENCE METHOD CHOLESTECH LDX – Sample Date Reference Method % Difference Acceptable Accuracy Range is ± Cholestech LDX Result – Ref. Result % Difference = x 100 Ref. Result Test Disposition Accept Reject Director Approval Approval Date <...
  • Page 66 PRECISION CALCULATION FORM (WITHIN-RUN) Date Operator Specimen Identification Analyte Cassette Lot No. Cholestech LDX Serial No. Accept Reject Director Approval Approval Date 1. Record the result of the quality control material in – – Column 2 – RESULT. Result Result – X (Result –...
  • Page 67 DATE 1. Has read User Manual. 2. Has read Procedure Manual. 3. Has viewed Cholestech LDX Training Video. 4. Has read Cholestech product insert. 5. Understands refrigerated and room temperature storage procedures for test cassettes. 6. Has been properly trained in procedure for handling biohazardous waste.
  • Page 70 Procedure Manual 3347 Investment Blvd. Hayward, CA 94545 U.S.A. Tel 800 733.0404 Cholestech LDX is a registered trademark of Cholestech Corporation. Fax 510 732.7227 MiniPet is a trademark of TriContinent Scientific, Inc. www.cholestech.com © 2003 Cholestech Corporation. 001 12517 Rev. B <...

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